An interventional study of Baracle Tab.® in Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation and Antiviral Drug, sponsored by Seoul St. Mary's Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Treatment
Among 77 studies in Hepatitis B with a site in Korea, Republic of — 4 open to participants now, 7 under way, 1 of them phase 3. Hepatitis B · Korea, Republic of.
Among the 77 studies in Hepatitis B with a site in Korea, Republic of, this one is the 10th largest by planned enrollment of the 71 interventional ones that give a count, is one of 8 that started in 2021, is one of 3 with no phase, and was the 62nd registered.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 226 is above the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →4 of the 77 studies in Hepatitis B with a site in Korea, Republic of are open now.
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 79 Hepatitis B studies recruiting now, 40 (51%) set no upper age limit and 34 (43%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 19 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →77 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 32 · Phase 3 15 · Phase 4 8
First in 2002; this study’s year is marked. 8 started in 2021.
Median enrollment 80 across the 71 interventional studies, 600 across the 3 observational. Of the 64 that completed or were terminated, 24 (38%) have results posted.
68 of 77 have an industry lead sponsor. The 10 most frequent:
Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
Seoul St. Mary's Hospital has 1 study filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
2 of the studies in Hepatitis B with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06963710Aligos TherapeuticsA Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME) | 2027-03 |
| NCT06537414GlaxoSmithKlineA Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) | 2027-05-31 |
Among the 77 studies in Hepatitis B with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with allogeneic hematopoietic stem cell transplantation.
This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with allogeneic hematopoietic stem cell transplantation.
In this study, patients are randomized into treatment group or delayed treatment group.
* Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.
Experimental: Treatment group (n=113) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after allogeneic hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.
* oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age: 19 - 70
(+, ≥10 IU/mL) at the time of screening
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after allogeneic hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.
Drug: Baracle Tab.®
The delayed treatment group (control group) visit clinic every month and examined liver function test, HBsAg/Ab for 3 years after allogeneic hematopoietic stem cell transplantation. HBV DNA level is examined at every 3 months for 3 years after allogenic hematopoietic stem cell transplantation. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Also known as: Prophylactic treatment group
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of HBV reactivation between the treatment and delayed treatment groups during 3 years after hematopoietic stem cell transplantation \* Definition of HBV reactivation: HBsAg ≥ 1.0 S/CO or HBV DNA ≥ 10 IU/mL
Time frame: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation
Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. \* Definition of active hepatitis: ALT \>= 2 times of upper normal limit
Time frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of hepatic failure between the treatment and delayed treatment groups.
Time frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
Time frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — According to the guideline of our institutional review board, the patient data could not be opened to other researchers.
Started Aug 2021 (actual). Primary completion is estimated for Dec 2028, 88 months after the start.
Of 62 non-industry interventional studies with no phase under Hepatitis B, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 88 months is above that.
Counting every sponsor, half of 68 studies reached it within 29 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Seoul St. Mary's Hospital